Actively Recruiting

Age: 18Years +
All Genders
NCT06321653

Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

Led by European Institute of Oncology · Updated on 2024-03-20

120

Participants Needed

1

Research Sites

454 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections.

CONDITIONS

Official Title

Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven invasive breast cancer
  • Breast conserving surgery without axillary dissection
  • Tumor size no more than 5 cm
  • No more than 2 positive sentinel lymph nodes
  • Negative surgical margin (no tumor cells on ink)
  • Performance status less than 2
  • Age over 18 years
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Previous thoracic radiotherapy
  • Mixed connective tissue disorders
  • Presence of distant metastases
  • Severe lung or heart diseases
  • Prior neoadjuvant systemic therapies
  • Axillary dissection performed
  • No surgical axillary investigation done
  • Mastectomy performed
  • Presence of axillary micrometastasis or isolated tumor cells

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

European Institute of Oncology

Milan, Italy

Actively Recruiting

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Research Team

M

Maria Cristina Leonardi, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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